Description:
In this webinar, we will explore how target-humanized mouse models can be integrated into non-clinical drug safety programs. We will discuss regulatory precedents and the growing global acceptance of these models, and present modality-specific case studies covering T-cell engagers (TCEs), antibody-drug conjugates (ADCs), and therapeutic antibodies in non-GLP toxicology studies. We will also share practical considerations for incorporating humanized mouse data into IND-enabling programs. In addition, we will present a reproductive toxicity study of cyclophosphamide in a target-humanized mouse model, highlighting the potential of humanized mice to support DART evaluation during post-IND development.
【講演概要】
本ウェビナーでは、標的ヒト化マウスモデルを非臨床安全性評価プログラムへ効率的に統合する方法を探ります。世界的な規制先例や受け入れ状況の拡大について解説するとともに、非GLP毒性研究におけるT細胞エンゲージャー（TCE）、抗体薬物複合体（ADC）、治療用抗体など、モダリティ別の具体的なケーススタディをご紹介します。また、ヒト化マウスのデータをIND（治験届）申請パッケージへ組み込むための実践的なアプローチも共有いたします。 さらに、標的ヒト化マウスモデルを用いたシクロホスファミドの生殖毒性研究事例を紹介し、IND以降の開発ステップにおけるDART（生殖発生毒性）評価をサポートするヒト化マウスの新たな可能性を提示します。
Speaker
Yuan Le, PhD
Manager and Principal Scientist
Biocytogen (Beijing) Pharmaceutical Co. Ltd.
Dr. Yuan Le is a Diplomate of the American Board of Toxicology (DABT). She received her PhD in Toxicology from St. John's University, New York, in 2020. Prior to joining Biocytogen, she served as a Visiting Scientist at the U.S. Food and Drug Administration's National Center for Toxicological Research (FDA/NCTR), where she led and participated multiple high-impact research programs focusing on respiratory toxicity, developmental toxicology, and safety assessment of nitrosamine drug impurities.
Dr. Le has extensive research experience in toxicology and in vitro alternative methods. Currently, she leads Biocytogen's organoid pharmacology and toxicology team, focusing on the establishment of organoid platforms and the development of drug toxicity evaluation systems using humanized mouse models.
